This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | SILK SUTURES |
| Classification Name | Suture, Nonabsorbable, Silk |
| Generic Name | Suture, Nonabsorbable, Silk |
| Applicant | LUKENS CORP. |
| Date Received | 1987-03-06 |
| Decision Date | 1987-04-24 |
| PMA | N80989 |
| Supplement | S001 |
| Product Code | GAP |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | LUKENS CORP. 51 Chubb Way somerville, NJ 08876 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N80989 | Original Filing | |
| S005 | 1988-07-20 | Normal 180 Day Track |
| S004 | 1988-05-24 | Normal 180 Day Track |
| S003 | 1988-02-24 | Normal 180 Day Track |
| S002 | ||
| S001 | 1987-03-06 | Normal 180 Day Track |